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Integrated Collaborative Care for Substance Use Disorders (SUMMIT)

25 april 2017 uppdaterad av: RAND

Primary care settings (PCS) are a missed opportunity for delivering evidence-based treatments for opiate and alcohol-use disorders (OAUD). The investigators propose to evaluate the costs and effectiveness of two strategies to increase the delivery of OAUD treatments in PCS, integrated collaborative care (ICC) and education and resources (E&R). The investigators hypothesize that ICC will be more effective than E&R in promoting A. Implementation outcomes B. Service system outcomes and C. Patient outcomes.

Results from our study will help providers choose between two different strategies and advance the field of implementation research.

Studieöversikt

Detaljerad beskrivning

Most individuals with opiate and alcohol-use disorders (OAUD) do not receive treatment. Primary care is an ideal setting in which to deliver OAUD treatment, yet evidence-based OAUD treatment is rarely provided.

Barriers to delivery include insufficient organizational support and lack of provider role models and clinical support. The investigators propose to evaluate the effectiveness of two strategies for increasing use of evidence-based treatment for OAUD within primary care: integrated collaborative care (ICC) and education and resources (E&R). While both strategies provide primary care practices with the same clinical information, ICC addresses these barriers by including organizational and technical support for delivering evidence-based care. ICC is grounded in the chronic care model and includes a behavioral health provider working as part of the care team.

Essential elements of ICC strategy include a decision support component to help providers with complex patients, and a restructuring of the delivery and clinical information systems to support the delivery of evidence-based care. Our approach to implementing ICC is based on the organizational transformation model and quality improvement. The investigators define the E&R strategy as providing printed educational materials and access to resources along with provider education. Both strategies are designed to increase the delivery of two evidence-based practices: motivational enhancement therapy and medication assisted therapy.

The investigators propose a 5-year mixed methods study and will conduct a RCT, with randomization occurring at the level of the care team and patient. The investigators partner with 5 Venice Family Clinic (VFC) clinics, two hospitals in LA County, and COPE Health Solutions. VFC is a large federally qualified health center (FQHC) and the largest free clinic in the United States. Our approach includes document review, focus groups, interviews, and surveys for obtaining data on the adoption process and implementation outcomes; analysis of patient records and patient surveys on service system and patient outcomes; and analysis of provider financial records and patient records and surveys for estimating costs. The investigators will enroll 400 patients with an OAUD diagnosis and follow them at 3 and 12 months. Our specific aims are: 1) To measure the process and extent of ICC and E&R implementation; 2) To test the effectiveness of ICC compared to an E&R strategy in promoting A. Implementation outcomes B. Service system outcomes and C. Patient outcomes; and 3) To estimate provider costs for each strategy. The investigators define implementation outcomes as measures of the acceptability, adoption, appropriateness, feasibility, and sustainability of evidence-based OAUD treatment. The investigators define service system outcomes as 1) process measures of treatment quality and 2) treatment co-morbidities. The investigators define patient outcomes as hospital readmissions, OAUD outcomes, patient functioning, negative consequences from substance use, and unmet need. The investigators define cost outcomes as start-up costs, operating costs and medical/psychiatric cost offsets.

Studietyp

Interventionell

Inskrivning (Faktisk)

397

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

    • California
      • Santa Monica, California, Förenta staterna, 90405
        • Venice Family Clinic-Simms Mann Health Center
      • Venice, California, Förenta staterna, 90291
        • Venice Family Clinic-Rose lAvenue

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  • opiate or alcohol use disorder
  • not currently in substance use disorder treatment
  • past 30 day use of alcohol or opioids
  • English or Spanish speaking

Exclusion Criteria:

  • co-morbid severe mental illness
  • medically unstable

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Hälsovårdsforskning
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: ICC
Integrated collaborative care
Aktiv komparator: E&R
Education and Resources--enhanced usual care

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
unmet need
Tidsram: past 6 months
Of those identified as screening positive for an opiate or alcohol use disorder, proportion who did not receive treatment for their substance use
past 6 months
abstinent from alcohol and opioid use, past 30 days
Tidsram: past 30 days
change in abstinence from alcohol and opioid use between baseline and 6 month follow up
past 30 days
negative consequences related to substance use
Tidsram: past 3 months
SIP-AD frequency questionnaire
past 3 months
Functioning
Tidsram: past 4 weeks
change in SF-12 between baseline and follow up
past 4 weeks
Engagement
Tidsram: 30 days of initiation
Proportion with at least 2 SUD-related visits within 30 days of initiation, Washington Circle
30 days of initiation
initiation
Tidsram: Within 14 days of index visit
Washington Circle initiation indicator--at least one SUD-related visit within 14 days of index visit
Within 14 days of index visit
heavy alcohol use
Tidsram: 6 months
among people at baseline with heavy alcohol use, proportion with heavy alcohol use in past 30 days
6 months

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Proportion initiating Brief therapy
Tidsram: 6 months
Proportion initiating brief therapy within 6 months
6 months
Proportion initiating MAT
Tidsram: 6 months
Proportion initiating MAT within 6 months, among those eligible for MAT, and if N's are large enough, stratified by type of MAT
6 months
abstinence from alcohol, opioids and all other drugs in the previous 30 days
Tidsram: collected at six months at the past 30 days
abstinence from alcohol, opioids and all other drugs in the past 30 days
collected at six months at the past 30 days

Samarbetspartners och utredare

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Sponsor

Publikationer och användbara länkar

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Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 juni 2014

Primärt slutförande (Faktisk)

1 september 2016

Avslutad studie (Faktisk)

1 januari 2017

Studieregistreringsdatum

Först inskickad

11 mars 2013

Först inskickad som uppfyllde QC-kriterierna

12 mars 2013

Första postat (Uppskatta)

13 mars 2013

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

27 april 2017

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

25 april 2017

Senast verifierad

1 april 2017

Mer information

Termer relaterade till denna studie

Läkemedels- och apparatinformation, studiedokument

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Nej

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Nej

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